Serialization and Beyond: A Post-Webinar Wrap-Up – Part Two

This the second and last part of the Serialization and Beyond webinar wrap-up. You can find the first part here.

Q: Now that serialization is a reality, are we seeing any problem areas in the supply chain where drugs cannot move forward due to transaction information (TI)/transaction history (TH)/transaction statement (TS) and general serial number problems? Are mistakes being made? Are there examples of things packaging departments can do better to avoid those problems?

A: The problems to date have been with the barcodes themselves. GS1 US and the “Big 3” wholesale distributors published a report in the fall documenting the problems they saw on barcodes the wholesalers received back in the May 2018 timeframe. The percentage of readable barcodes with the correct DSCSA contents was shockingly low. So far this is the only report of issues that are avoidable.

Regarding TI, TH, and TS, these requirements have been in place since 2015, so no new problems have been reported. The supply chain seems to have adjusted to those older requirements. However, McKesson has received a Form 483 from the FDA because of their lack of proper DSCSA record-keeping and follow-up.

Q: For solid oral dosages, is there going to be a requirement in the near future to serialize each individual dose unit?

A: No, we don’t foresee this ever happening. The purpose of serialization today is to use the serial numbers to trace the movement of drugs through the supply chain. The supply chain is where the risk of counterfeit, theft and diversion occur. Dose serialization doesn’t get you any closer to solving those problems than applying anti-counterfeiting technologies do at the package level.

Q: Will it work on blister? Or only on labels / packaging?

A: In serialized pharmaceuticals, the solution works with the 2D datamatrix barcode used for compliance. This barcode and human readable component are typically on labels/packaging, not on the blister pack itself.

Q: It appears as though the China Food and Drug Administration (CFDA) is not planning on standing up a centralized track and trace system as part of their new regulation (based on initial drafts). Do you believe the industry or manufacturers will be successful in banding together to create this system? Is a more directed approach by the government and a government operated centralized system required to meet track and trace regulations to help combat diversion and counterfeiting?

A: Based on the document translations we’ve seen so far, we don’t think there is enough information, or enough of a mandate, to get the industry to band together. We assume more is coming that might fix that, but we’ll have to wait and see. Perhaps it will be the more direct approach you suggest. It appears that China likes the EU model where the regulation simply dictates that the industry create a solution that works, and they pay for it themselves. Unfortunately, if that’s what they are trying to achieve, they will need to get a lot more specific. The EU Delegated Regulation works because it was very clearly written and included solid mandates. China has a long way to go to get to that same level of mandate, but that could be fixed with a single, well-written, well thought-out decree.

Fortunately Systech’s solutions can be used with or without a solid mandate from the government. It allows companies to take matters into their own hands wherever there is a threat or reality of counterfeiting and diversion, and at a much lower cost than government mandated serialization.

Q: Does the Systech optical equipment for production line generate line validation for GAMP compliance or could we avoid this step as this is just an added optical device?

A: Please refer to your internal validation standards when coming to a final determination on this issue. The Systech authentication capabilities and solution are not part of the serialization environment. It is normally a separately added camera on the packaging line, which is integrated with an entirely different data environment.

Q: Regulators are going to require verification of serialized products in 2019. Is digital authentication going to be able to meet that requirement?

A: UniSecure is a brand protection technology, and absolutely not a compliance technology. Serialization is pharmaceutical compliance. To meet regulatory requirements like the DSCSA, you have to follow the requirements spelled out by the DSCSA and the industry. The kind of digital authentication that UniSecure offers is for use by the manufacturer, law enforcement and healthcare and supply chain professionals in markets where counterfeiting and diversion is a known serious problem, unlike the US pharma market. There are many other, non-regulated products in the US where counterfeiting and diversion are serious problems.

Q: How does a "bolt on" connect the digital authentication with the serialized UPI EPCIS data repository and data transactions (on smartphone app)?

A: They don’t integrate. The digital authentication technology used on the smartphone is enabled by simply capturing a high-resolution image of every barcode (serialized or not) of the product during packaging. The data is compressed and then uploaded to a cloud repository where it is accessed by the smartphone app. No need to integrate with the compliance database.

Q: Does your solution span L1 to L5?

A: We like to consider our authentication solution as L5. Serialization compliance, including global track and trace, is accomplished with our L1 through L4 set of solutions. Digital e-Fingerprinting, and product authentication is outside of compliance.

Q: Will the packaging line camera system perform the normal serialization/quality inspections OCV/OCR and data matrix decode/verification, along with saving of the image for authentication? Or is it a separate system?

A: If the packaging line serialization solution is from Systech, the data matrix barcode verification camera can also be used for capturing the fingerprint data. For lines that do not use a Systech solution, one additional camera would be added to the line so that the UniSecure solution can capture and derive the fingerprints. Even in a Systech serialization line, an additional camera can be added for capturing fingerprints if that allows the packager to avoid re-validating the line.

Q: Not everyone in Africa has smartphones with "good" (autofocus, high resolution) cameras. Does this fact limit in any way the target users of the Systech-powered mobile app?

A(from Takeda): The target users in Africa are actually Takeda employees and designated supply chain partners – not end-patients. If and when we decide to move forward with broader patient applications with the smartphone authentication solution, the smartphones that would be in the region should be suitable by that time.

Q: Do you need aggregation capabilities to make the DA (digital authentication) solution work?

A: Aggregation is not needed for the anti-counterfeiting use case. A form of aggregation is necessary for most diversion use cases to more easily facilitate knowing which e-Fingerprinted items were shipped to which customer. Later, when you find diverted product, you can easily determine which customer originally received those products using the aggregation data associated with the items.

Q: Are you also expecting to combat parallel trading/imports with this solution?

A: Yes, to the extent that it will allow you to know, with complete confidence, exactly which of your customers sourced the product that is found in the parallel trade path. Using that information, you can then work with that customer to stop the diversion. Once the customer is alerted, you can probably get them to stop selling it to unauthorized buyers.

Q: Has the Takeda DA (Digital Authentication) solution undergone regulatory review or been subject to an inspection yet?

A: The Digital Authentication solution is not subject to regulatory review or inspection at this time. We would encourage regulators to look at broad adoption of digital e-Fingerprinting and authentication to augment serialization as a powerful tool against rampant counterfeiting.

Q: Regarding the pricing, versus serialization equipment and software, how much does it cost per line including certification?

A: Compared to other additive brand protection solutions in the market, Systech’s digital authentication solution is a fraction of the cost. Considering the solution leverages existing barcodes created through investment in serialization for compliance, there is almost instant return on investment.

Q: Does the solution "compensate" for potential barcode quality degrading from point of manufacturing to point of authentication? (i.e False Rejects)

A: Another GREAT question from the audience. We absolutely anticipate quality degradation of the package and even more extreme damage conditions of the barcode we’re analyzing. We are able to deal with downstream issues with quality and damage quite well. If there is such significant damage/alteration that we register a False Reject (we generally call this a “Suspect”), we would anticipate brands would question the care and handling of the product and would be fine with that result.

Disclaimer on Regulatory Information

This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions.